Regulatory toxicology and pharmacology : RTP
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Regul. Toxicol. Pharmacol. · Aug 2014
Cannabis, pesticides and conflicting laws: the dilemma for legalized States and implications for public health.
State laws on the legalization of medical and recreational cannabis are rapidly evolving. Similar to other crops, cannabis is susceptible to multiple pests during cultivation. Growers have an economic incentive to produce large yields and high quality plants, and may resort to pesticides to achieve these outcomes. ⋯ The absence of approved products for cannabis may result in consumer exposures to otherwise more hazardous pesticides or higher residue levels. While many legal and scientific hurdles exist to register conventional pesticides for use on cannabis, legalized States have explored other opportunities to leverage the present regulatory infrastructure. Stakeholder engagement and outreach to the cannabis industry from credible sources could mitigate pesticide misuse and harm.
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Regul. Toxicol. Pharmacol. · Feb 2014
Pre-clinical safety evaluation of the synthetic human milk, nature-identical, oligosaccharide 2'-O-Fucosyllactose (2'FL).
In order to match the composition of human breast milk more closely, it is now possible to supplement commercial infant formula (IF) with synthesised oligosaccharides that are chemically identical to human milk oligosaccharides. The safety data generated on a new human-identical milk oligosaccharide (HiMO), 2'-O-Fucosyllactose (2'FL), are presented. Standard in vitro genotoxicity tests were performed. ⋯ Oral administration up to 5000 mg/kgbw/day to rats over 90 days was not associated with any adverse effects based on clinical observations, body weight gain, food consumption, ophthalmoscopy, clinical pathology, organ weights and histopathology findings. Based on this 90-day study, a No Observed Adverse Effect Level (NOAEL) of 5000 mg/kgbw/day for both male and female rats was established for 2'FL. These findings support the safety of synthetic 2'FL for possible use in infant food.
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Regul. Toxicol. Pharmacol. · Dec 2013
Estimation of mouth level exposure to smoke constituents of cigarettes with different tar levels using filter analysis.
A nicotine part-filter method can be applied to estimate smokers' mouth level exposure (MLE) to smoke constituents. The objectives of this study were (1) to generate calibration curves for 47 smoke constituents, (2) to estimate MLE to selected smoke constituents using Japanese smokers of commercially available cigarettes covering a wide range of International Organization for Standardization tar yields (1-21mg/cigarette), and (3) to investigate relationships between MLE estimates and various machine-smoking yields. Five cigarette brands were machine-smoked under 7 different smoking regimes and smoke constituents and nicotine content in part-filters were measured. ⋯ Nicotine content in part-filters was then measured and MLE to each smoke constituent was estimated. Strong correlations were identified between nicotine content in part-filters and 41 out of the 47 smoke constituent yields. Estimates of MLE to acetaldehyde, acrolein, 1,3-butadiene, benzene, benzo[a]pyrene, carbon monoxide, and tar showed significant negative correlations with corresponding constituent yields per mg nicotine under the Health Canada Intense smoking regime, whereas significant positive correlations were observed for N-nitrosonornicotine and (4-methylnitrosoamino)-1-(3-pyridyl)-1-butanone.
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Regul. Toxicol. Pharmacol. · Dec 2013
ReviewCharacterisation and toxicological assessment of Neutral Methacrylate Copolymer for GRAS evaluation.
Neutral Methacrylate Copolymer is a fully polymerised copolymer used in the pharmaceutical industry to permit pH-independent delayed release of active ingredients from oral dosage forms. This function has potential use with food supplements and this article describes available information on the safety of the substance. Oral administration of radiolabelled copolymer to rats resulted in the detection of chemically unchanged copolymer in the faeces, with negligible absorption. ⋯ Daily exposure from use in dietary supplements is estimated as up to 10.0 mg/kg bw in adults and 13.3 mg/kg bw in children. There would therefore appear to be no safety concerns under the intended conditions of use. The information provided is intended to support an evaluation that the substance may be "generally recognized as safe" (GRAS).
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Regul. Toxicol. Pharmacol. · Dec 2013
Pharmaceutical risk management in Turkey: the first national overview.
Risk management plans and actions aim to limit the known risks of drugs and provide valuable data to evaluate actual risks and pre-disposing factors for adverse drug reactions. In this study, it is aimed to evaluate and summarize the risk management actions in Turkey between 2005 and 2013 for the first time. ⋯ Various risk management actions such as provision of information, summary of product characteristics and patient information leaflets, direct communication with healthcare professionals, patient and physician brochures, change of the legal status of the drug, education of doctors and pharmacists, control of number and validity of prescriptions, using informed consent forms, using "drug safety surveillance form" for the TNF blockers (firstly on the world), using web-based monitoring system, web-based prescription and web-based adverse reaction monitoring system were used for safe use of drugs during and after authorization in Turkey. Although, most of the actions are similar to those of international health authorities, the remaining are specific to the conditions of Turkey such as "drug safety surveillance form" for the TNF blockers.